Replies to post #230988 on Biotech Values

[sab63090]

@jq1234
Thanks for that message. It certainly seems the best and the timing is outstanding.

[DewDiligence]

ABT will soon launch an IgM COVID-19 lab-based serology test to complement the IgG test launched yesterday. ABT is also working on a lateral-flow point-of-care COVID-19 serology test. Source: 1Q20 CC today.

[DewDiligence]

Re: Sensitivity/specificity of ABT’s IgG* COVID-19 test

ABT serology test - blood based antibody test - for covid-19 is the best I have seen overall so far, 100% sensitivity and 99.5% specificity.

Just to be clear: The above figures—100% and 99.5%, respectively—are for individuals who are tested >=14 days after the disappearance of COVID-19 symptoms, or those who never had COVID-19 symptoms. Tests taken sooner than 14 days after the disappearance of symptoms would have lower sensitivity since it takes some time for IgG antibodies to be detectable.

This type of sensitivity and specificity is needed for large population with currently estimated prevalence.

Also for smaller defined populations such as employees at a given factory or office building.

*ABT’s IgM serology test is under development (#msg-155072306).

[DewDiligence]

Italy selects ABT’s COVID-19-antibody test:

https://finance.yahoo.com/news/italy-picks-u-firm-abbott-154513719.html

This is ABT’s IgG test that was launched in the US on 4/15/20 (#msg-155023286, #msg-155047190). ABT is also developing an IgM test that the company says will be available soon.

[DewDiligence]

ABT’s COVID-19 IgG test receives FDA EUA:

In FDA’s continuing effort to increase the availability of serology – i.e. antibody – tests, we issued an emergency use authorization (EUA) to Abbott Laboratories Inc. for its SARS-CoV-2 IgG serology test. This is FDA’s eighth EUA for a serology test. https://t.co/PjWkgj2R2Q pic.twitter.com/u6henGBRNl

— Dr. Stephen M. Hahn (@SteveFDA) April 27, 2020

[DewDiligence]

ABT’s IgG test is even better than advertised, according to this independent analysis:

https://www.medrxiv.org/content/10.1101/2020.04.27.20082362v1

We tested 1,020 serum specimens collected prior to SARS-CoV-2 circulation in the United States and found one false positive, indicating a specificity of 99.90%. We tested 125 patients who tested RT-PCR positive for SARS-CoV-2 for which 689 excess serum specimens were available and found sensitivity reached 100% at day 17 after symptom onset and day 13 after PCR positivity.

[DewDiligence]

UK selects ABT’s COVID-19 IgG-antibody test:

https://www.prnewswire.com/news-releases/abbott-announces-contract-to-supply-millions-of-igg-lab-based-antibody-tests-to-the-uk-government-301063846.html